The trial aims to assess the long-term efficacy and safety of lanifibranor in adults with biopsy-proven non-cirrhotic MASH/NASH. Credit: Emily frost / Shutterstock.

Inventiva has announced the latest developments in its Phase III NATiV3 clinical programme assessing lanifibranor to treat metabolic dysfunction-associated steatohepatitis / non-alcoholic steatohepatitis (MASH/NASH).

The recruitment process in the trial is actively underway at 347 sites across 19 countries.

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Employing a randomised, double-blind, placebo-controlled design, the trial aims to assess the long-term efficacy and safety of lanifibranor in adults with biopsy-proven non-cirrhotic MASH/NASH and F2/F3 stage liver fibrosis.

The trial aims to enrol approximately 900 patients for a 72-week treatment duration.

Key histological endpoints, including the resolution of MASH/NASH and the improvement of fibrosis by at least one stage, will be evaluated to determine lanifibranor’s potential.

Additionally, an exploratory cohort will enrol around 200 patients who did not meet the histology criteria for the main NATiV3 clinical trial.

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As of 5 July, the trial randomised 1,027 patients, with 784 in the main cohort, reaching 82% of the targeted enrolment. The exploratory cohort has exceeded its recruitment target, with 243 patients randomised.

Despite a recruitment delay of three to five months, Inventiva is aiming for the last patient’s first visit to occur in the second half of this year

Topline trial results are expected in the early second half of 2026.

The company has reported that the baseline characteristics of patients in the main cohort align with expectations and are consistent with the NATIVE Phase IIb clinical trial results.

A blinded review of 780 patients in the main cohort revealed a weight gain pattern similar to that observed in the NATIVE Phase IIb trial, which appears to plateau after 24 to 36 weeks, even among patients with over 5% weight gain.

Inventiva chairman, CEO and co-founder Frederic Cren said: “We have made good progress with the recruitment in our Phase III clinical trial and continue to see a strong engagement of clinical trial sites in NATiV3.

“We are encouraged by the patient characteristics we are seeing in the main cohort of NATiV3 compared to those of our Phase IIb trial and above all by the plateau effect we see in the weight gain curve which confirms the differentiated profile of our panPPAR compound versus single PPAR gamma compounds such as pioglitazone.

“The data obtained from our various clinical studies demonstrate that lanifibranor could fully address the broad spectrum of the disease and recently presented data at the EASL Liver Congress from other compounds in development further bolster our belief in the potential of oral lanifibranor for use alone or in combination therapy.”